The present invention relates generally to intraluminal grafts or xe2x80x9cstentsxe2x80x9d and, more specifically, to improved-guidewire-access modular intraluminal prostheses having a sealing section where one module attaches to another.
A stent is an elongated device used to support an intraluminal wall. In the case of a vascular stenosis, a stent provides an unobstructed conduit for blood in the area of the stenosis. Such a stent may also have a layer of prosthetic material that covers or lines the inside or outside thereof. Such a covered or lined stent is commonly referred to in the art as an intraluminal prosthesis, an endoluminal or endovascular graft (EVG), or a stent-graft. As used herein, however, the term xe2x80x9cstentxe2x80x9d is a shorthand reference referring to a covered or uncovered such stent.
Such a prosthesis may be used, for example, to treat a vascular aneurysm by removing the pressure on a weakened part of an artery so as to reduce the risk of rupture. Typically, an intraluminal stent or prosthesis is implanted in a blood vessel at the site of a stenosis or aneurysm endoluininally, i.e. by so-called xe2x80x9cminimally invasive techniquesxe2x80x9d in which the stent, restrained in a radially compressed configuration by a sheath or catheter, is delivered by a stent deployment system or xe2x80x9cintroducerxe2x80x9d to the site where it is required. The introducer may enter the body through the patient""s skin, or by a xe2x80x9ccut downxe2x80x9d technique in which the entry blood vessel is exposed by minor surgical means. When the introducer has been threaded into the body lumen to the stent deployment location, the introducer is manipulated to cause the stent to be released from the surrounding sheath or catheter in which it is restrained (or alternatively the surrounding sheath or catheter is retracted from the stent), whereupon the stent expands to a predetermined diameter at the deployment location, and the introducer is withdrawn. Stent expansion may be effected by spring elasticity, balloon expansion, or by the self-expansion of a thermally or stress-induced return of a memory material to a pre-conditioned expanded configuration.
Modular stents and prostheses are known in the art for in vivo assembly, particularly as applied to a bifurcated artery or vein, such as, for example, the bifurcation in the mammalian aortic artery into the common iliac arteries. The endoluminal navigation of a second component to find and mate with a previously deployed first component can be difficult.
Typically, the surgeon must navigate a guidewire to find an opening in the previously placed component, where the second component is to be mated therewith. Because of the tortuosity of the anatomy, the difficulty of visualizing that opening via fluoroscopy, and the two-dimensional nature of the fluoroscopic image, accessing that opening with the guidewire is one of the most difficult and time-consuming aspects of deploying such a prosthesis. Additionally, because of the difficulty in making the connection with that opening, the guidewire may inadvertently miss the opening and dislodge thrombus or pierce a wall of the lumen in which the prosthesis is being placed.
In a design known prior to the invention and as shown in FIG. 1, a body 30 disposed in the infrarenal area of the aorta with an integral elongated segment 32 extending into a first iliac artery 16 also comprises an integral funnel-shaped segment 34 alongside the elongated segment. Funnel-shaped segment 34 is adapted to capture guidewire 18 introduced from the iliac artery 16xe2x80x2 into mouth 36 and to prevent the guidewire from contacting artery wall 26. The second modular component of the graft 37 is then inserted along guidewire 18 into funnel-shaped segment 34 from the iliac artery 16xe2x80x2 and thus guided to a connection with first part body 30 at port 38. No particular type of connection between body 30 and second modular component 37 is disclosed in this prior known construction except as shown in FIG. 1.
The present invention provides an intraluminal prosthesis adapted for insertion into and assembly within a body lumen to repair the lumen. The prosthesis comprises a female mating member comprising a main body portion, a funnel-shaped end, a connecting segment connecting the main body portion to the funnel-shaped end; and a male mating member adapted for secure and/or fluid-tight assembly with the connecting segment of the female mating member. The connecting segment may be essentially cylindrical or it may taper with decreasing diameter from the main body to the funnel-shaped end. The connecting segment and adjacent funnel-shaped end may together form an hourglass-shaped end.
A biocompatible material may cover one or both of the inner mating surface of the sealing segment and the outer mating surface of the male mating member adapted for contact with the sealing segment. The biocompatible graft material may cover the inner surface of the funnel-shaped end, and in particular, may cover the outer surface of the entire prosthesis except for the funnel-shaped end, which is covered only on the inner surface thereof.
The prosthesis may be bifurcated into first and second extensions depending from the main body section, wherein one or both of the extensions comprise an integral female mating member with a connecting segment as disclosed and claimed herein. One extension may comprise an integral first leg member that depends from the main body alongside the integral female mating member extension into which the male mating member mates to comprise a second leg member. Specifically, the prosthesis may form a bifurcated aortic intraluminal prosthesis adapted for deployment in the infra-renal aorta and the iliac arteries, where the main body component forms the main aortic body, the integral first leg member forms the first iliac segment, and the second leg member forms the second iliac segment.
It is to be understood that both the foregoing general description and the following detailed description are exemplary, but are not restrictive, of the invention.